510(k) · Cleared
Recalled · Class II · 2017Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporate · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Sep 8, 2014 as substantially equivalent to K002732 (Stryker Corp., 2000) and 2 other predicates after an 89-day review. Its family tree reaches back 2 generations to 2000. 20 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- PGW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K993239 (2000). 5 ancestors in all. 20 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 1 generation backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- This deviceK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014
- Descendant · cites it directly · 17 of its ownK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
- Descendant · 2 generations on · 16 of its ownK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
- Descendant · 3 generations on · 12 of its ownK172034 Stryker Spine Navigation System with SpineMap 3D software…Stryker Corporation · 2017
- Descendant · 3 generations on · 10 of its ownK220593 Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022
- Descendant · 4 generations on · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K153240Styrker OrthoMap Express Knee SystemStryker Corporate · 2016 · cites it directly17descendants
- K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016 · 2 generations on16descendants
- K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation · 2017 · 3 generations on12descendants
- K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022 · 3 generations on10descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −1 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| 0 (this device) | K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70… | Stryker Corporate | 2014 | — |
| +1 | K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 | — |
| +2 | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
| +3 | K172034 | Stryker Spine Navigation System with SpineMap 3D software application… | Stryker Corporation | 2017 | — |
| +3 | K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| +4 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGW device
- #1 K261540 Cube 4D Navigation System, VirtuEye Proscore 12.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002732 | Stryker Navigation System - Ent ModuleSummary page 6…Predicate Substantial Number Date Equivalence Characteristic Stryker Navigation System – ENT K002732 10/01/2000 Navigated Surgical Instruments Module Stryker Navigation System – Cranial K062640 12/14/2006… | 2000 |
| * | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000Summary page 6…Characteristic Stryker Navigation System – ENT K002732 10/01/2000 Navigated Surgical Instruments Module Stryker Navigation System – Cranial K062640 12/14/2006 Application Software Module Patient Refere… | 2006 |
| * | K130874 | Stryker NAV3I PlatformSummary page 6…Patient Reference Localizer Registration Accessories Stryker NAV3i Platform K130874 09/27/2013 Computer Platform TABLE 5-1 PREDICATE DEVICES… | 2013 |
What descends from it? (20)
See all 202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2017 | Class II | Z-2071-2017 | Storage | Product shipped proximate to or past the expiration date listed on the product label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K153240 (Stryker Corporate, 2016) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K002732.
How does its category compare?
All PGW devicesPGW Ear, Nose, And Throat Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGW
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGW
220in 2025
MAUDE reports naming product code PGW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 116 | 0 | 7 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 9 | 115 | 0 | 33 |
| 2017 | 4 | 125 | 0 | 42 |
| 2018 | 2 | — | 0 | 96 |
| 2019 | 1 | — | 3 | 247 |
| 2020 | 8 | 100 | 0 | 161 |
| 2021 | 1 | — | 1 | 190 |
| 2022 | 2 | — | 0 | 166 |
| 2023 | 2 | — | 1 | 200 |
| 2024 | 0 | — | 0 | 274 |
| 2025 | 1 | — | 1 | 220 |
| 2026 | 3 | 65 | 0 | — |
What is it indicated for?
The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure…
Read the full statement (122 words)
The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available.
The Stryker PROFESS™ system supports the following surgical procedures:
• Endoscopic sinus surgery
• Intranasal procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141551
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026